Title 21, Part 26 — Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
64 sections
Section 26.0
General.
Section 26.1
Definitions.
Section 26.2
Purpose.
Section 26.3
Scope.
Section 26.4
Product coverage.
Section 26.5
Length of transition period.
Section 26.6
Equivalence assessment.
Section 26.7
Participation in the equivalence assessment and determination.
Section 26.8
Other transition activities.
Section 26.9
Equivalence determination.
Section 26.10
Regulatory authorities not listed as currently equivalent.
Section 26.11
Start of operational period.
Section 26.12
Nature of recognition of inspection reports.
Section 26.13
Transmission of postapproval inspection reports.
Section 26.14
Transmission of preapproval inspection reports.
Section 26.15
Monitoring continued equivalence.
Section 26.16
Suspension.
Section 26.17
Role and composition of the Joint Sectoral Committee.
Section 26.18
Regulatory collaboration.
Section 26.19
Information relating to quality aspects.
Section 26.20
Alert system.
Section 26.21
Safeguard clause.
Section 26.31
Purpose.
Section 26.32
Scope.
Section 26.33
Product coverage.
Section 26.34
Regulatory authorities.
Section 26.35
Length and purpose of transition period.
Section 26.36
Listing of CAB's.
Section 26.37
Confidence building activities.
Section 26.38
Other transition period activities.
Section 26.39
Equivalence assessment.
Section 26.40
Start of the operational period.
Section 26.41
Exchange and endorsement of quality system evaluation reports.
Section 26.42
Exchange and endorsement of product evaluation reports.
Section 26.43
Transmission of quality system evaluation reports.
Section 26.44
Transmission of product evaluation reports.
Section 26.45
Monitoring continued equivalence.
Section 26.46
Listing of additional CAB's.
Section 26.47
Role and composition of the Joint Sectoral Committee.
Section 26.48
Harmonization.
Section 26.49
Regulatory cooperation.
Section 26.50
Alert system and exchange of postmarket vigilance reports.
Section 26.60
Definitions.
Section 26.61
Purpose of this part.
Section 26.62
General obligations.
Section 26.63
General coverage of this part.
Section 26.64
Transitional arrangements.
Section 26.65
Designating authorities.
Section 26.66
Designation and listing procedures.
Section 26.67
Suspension of listed conformity assessment bodies.
Section 26.68
Withdrawal of listed conformity assessment bodies.
Section 26.69
Monitoring of conformity assessment bodies.
Section 26.70
Conformity assessment bodies.
Section 26.71
Exchange of information.
Section 26.72
Sectoral contact points.
Section 26.73
Joint Committee.
Section 26.74
Preservation of regulatory authority.
Section 26.75
Suspension of recognition obligations.
Section 26.76
Confidentiality.
Section 26.77
Fees.
Section 26.78
Agreements with other countries.
Section 26.79
Territorial application.
Section 26.80
Entry into force, amendment, and termination.
Section 26.81
Final provisions.